The application be on March 23rd, 2017 submit, entitled " mitral ", application No. isThe divisional application of the application for a patent for invention of (201680002886.0 international application no PCT/US2016/060729).
Specific embodiment
In the following detailed description, numerous specific details are set forth to provide and this subject technology is understood completely.It answersWork as understanding, this subject technology can be implemented in the case where some in these details.In other cases, do not haveIt is shown specifically well known structure and technology, in order to avoid obscure this subject technology.
In addition, although disclosure sets forth the details of various embodiments, but it is to be understood that the description is only explanationProperty, it is restrictive without that should be not construed as in any way.Additionally, it is contemplated that although can be in mitralBackground under disclose or show the particular embodiment of the present invention, but such embodiment can be used for other heart valve prosthesisUsing.In addition, the various applications of such embodiment and its variation example that those skilled in the art are contemplated that are also included within this paper instituteIn the basic conception stated.
As all cardiac valves film, healthy bicuspid valve allows blood flow by opening and closes anti-to prevent Hemostatic Oral LiquidStream.However, the disease and dysfunction of valve, which can lead to reflux or blood flow, to be reduced.In such cases, it is necessary to using artificialMitral executes the mitral function of health.
However, in terms of providing artificial mitral valve prosthese, there are many challenges.For example, in order to overcome reflux or blood flow to dropLow problem, when relative to self bicuspid valve and annulus of mitral valve positioning and release, suitable artificial mitral valve prosthese must be mentionedFor the acceptable sealing with self mitral valve tissue.In addition, the structure (including under aorta-bicuspid valve every) of annulus of mitral valve also existsChallenge is generated in the design of mitral.In fact, mitral must comply with mitral unique anatomical structure, andAnchoring is kept in the case where there is the continuous contraction of the heart worked normally.
The present invention describes the device and method for using minimally invasive surgery technology implantation mitral.The device accommodatesMitral labyrinth, to ensure that the prosthese being implanted into is properly located and is firmly held in place after the implants.In addition, some embodiments additionally provide may include delivery apparatus and mitral mitral delivery system.
Mitral may include anchoring element and the valving members for being connected to anchoring element.Valving members can haveMultiple artificial leaflets of its inner surface are attached to, valving members can simulate self mitral function.Valving members and anchoringElement can have for delivery to the compactly designed of diseased valve and discharge and be implanted into lesion annulus in when expansion orExpanded configuration.
In addition, in some embodiments, valving members and anchoring element can the non-overlapping configuration positioning with series configurationIn delivery system, to reduce the diameter of valving members during delivering.
In addition, in some embodiments, valving members can be flexibly coupled to anchoring element, with provide anchoring element andThe effective position of valving members.For example, valving members can be connected with anchoring element by flexible member, so that in heart or certainlyBefore discharging valving members in body annulus and expanding valving members, valving members and anchoring element can be longitudinal relative to each otherGround rotatably moves.In addition, valving members and anchoring element can be unfolded from compact condition or be expanded to unfolded state, andIt is unfolded or expands independently of one another in some embodiments.
Heart valve anatomy and prosthetic valve replacement
Fig. 1 shows the schematic cross sectional views of human heart 10.Heart 10 may include atrium dextrum 12, right ventricle 14, a left sideVentricle 16 and atrium sinistrum 18.Oxygen deprivation blood enters atrium dextrum 12 by superior vena cava 20 and inferior caval vein 22.Oxygen deprivation blood is from the right sideAtrium is pumped across tricuspid valve 24 (it separates atrium dextrum 12 and right ventricle 14), and enters right ventricle 14.Right ventricle 14 is rightOxygen deprivation blood is pumped across pulmonary valve 26 afterwards and enters pulmonary artery 28, oxygen deprivation blood is directed to lung with by oxygen by pulmonary artery 28Gas is transferred to oxygen deprivation blood.Hereafter, oxygen-rich blood passes through pulmonary vein 30 from lung and is transported to atrium sinistrum 18.Oxygen-rich blood is from the left heartRoom 18 is pumped across bicuspid valve 32 and enters left ventricle 16.Then oxygen-rich blood is pumped across aorta petal 34 by left ventricle 16And enter aorta 36.Oxygen-rich blood is transported to a series of arteries by aorta, and blood is transported to intracorporal by a series of this arteryVarious organs.
Bicuspid valve 32 (also referred to as mitral valve or left atrioventricular valve) opens and closes, to control the oxygen-rich blood from heartFlowing.When the relaxation of left ventricle 16, the blood from atrium sinistrum 18 fills left ventricle 16.When left ventricle 16 is shunk, ventricle 16The increase of interior pressure closes bicuspid valve 32, to prevent blood leakage to atrium sinistrum 18, and ensures to leave left ventricle 16Whole blood pass through aorta petal 34 be discharged to aorta 36 and reach body.
Fig. 2-Fig. 4, which is shown, is implanted with mitral 50 to substitute the broken section of the heart 10 of self bicuspid valve 32Figure.Fig. 2 is the enlarged drawing for showing the bicuspid valve 32 of heart 10, and Fig. 3 is shown across the bottom of the valve plane of heart 10 viewFigure or ventricle view, and Fig. 4 shows the top view or atrium view of bicuspid valve 32.According to some embodiments, bicuspid valveProsthese 50 may include anchoring element 52 and valving members 54.Anchoring element 52 can anchor (or engagement) to self bicuspid valve 32With the anatomic structures of surrounding tissue, and valving members 54 may include multiple leaflets, and leaflet is for providing blood across two pointsThe one-way flow of valve 32.
For example, ventricular side (as shown in Figures 2 and 3), anchoring element 52 can be with the tendon that extends downwardly from bicuspid valve 32Rope 60 engages, to be anchored on outside and inside papillary muscle 62.In addition, in some embodiments, anchoring element 52 can be with twoThe annulus of mitral valve 80 of cusp 32 engages.Annulus of mitral valve 80 is the fibrous ring with front and rear.Annulus of mitral valve 80 is around two pointsThe circumference of valve 32 extends.Annulus of mitral valve 80 is connected with the highest point formed by preceding annulus 82 and rear annulus 84 and in rear outsideThe three-dimensional saddle structure (hyperbolic-parabolic) of minimum point at conjunction portion 86 and preceding inside commissure 88.Annulus of mitral valve 80 and aortaAnnulus 90 is substantially adjacent.Between annulus of mitral valve 80 and aortic valvular ring 90 is every 92 under aorta-bicuspid valve, activelyIt every 92 is following fibre structure under arteries and veins-bicuspid valve, the fibre structure is by the preceding annulus 82 of annulus of mitral valve 80 and aortic valvular ring 90Close connection, and terminate at two outside lefts (itself and the rear outside commissure 86 and preceding inside commissure 88 of bicuspid valve 32It is adjacent), to form left fibrous trigone area 94 and right fibrous trigone area 96.
Mitral
Referring now to figure 5-8 B, the various constructions of mitral 100 and its component are shown in figure.Mitral100 may include valving members 110 and anchoring element 120, and valving members 110 are connected to anchoring element 120.In some embodimentsIn, valving members 110 can be flexibly coupled to anchoring element 120 via coupler component 122, and the one of coupler component 122Side end is attached to anchoring element 120, and its end side is attached to valving members 110.Coupler component 122 is in Fig. 5It is shown as multi-filament line 124a, 124b, 124c.As discussed herein, the flexibility of valving members 110 and anchoring element 120Interconnection can provide advantage in delivering, in terms of the appropriate function placing and ensure mitral 100.
Fig. 5 is also shown: in some embodiments, anchoring element 120 may include by least one flexible connector 140One or more supporting elements interconnected amongst one another, ring structure part, wire rod component.Flexible connector 140 may include connection anchoring memberAt least one sheet material, tubular part or the material chain of two or more components of part 120.For example, flexible connection shown in fig. 5Device 140 may include tubular skirt structure, and the top of the tubular skirt structure is connected to the upper supporting piece 150 of anchoring element 120,And the lower end of the tubular skirt structure is connected to the lower support element 152 of anchoring element 120.Upper supporting piece 150 and lower support element152 additional detail will be discussed further below.
Fig. 5 shows the valve prosthesis 100 in separation structure, wherein valving members 110 in the longitudinal direction with anchoring element120 are not overlapped, but are spaced apart in the longitudinal direction with anchoring element 120 along the central axis of valve prosthesis 100 or longitudinal axis 142And it is adjacent.Shown separation structure shows anchoring element 120 and can be placed in bicuspid valve, that is, is placed on left ventricle and the left heartIn heart between room, and it is secured in position before valving members 110 are released and are located in bicuspid valve.In addition, such as thisWhat text was discussed, coupler component 122 can promote engagement and alignment between valving members 110 and anchoring element 120, this canTo allow valving members 110 and anchoring element 120 to be independently unfolded or expand, the structure positioning relative to heart and release.CauseVarious advantages may be implemented as discussed herein in this during operative treatment.
Fig. 6 shows the mitral 100 in assembled configuration, and wherein valving members 110 are default in anchoring element 120Position and expansion, the construction be implanted in the self annulus of patient with mitral 100 after construction as.In anchoring element120 is stretched and after being located in bicuspid valve, and valving members 110 can be positioned and be expanded in anchoring element 120.OneIn a little embodiments, during the implantation of valve prosthesis 100, valving members 110 have only been placed on and anchoring element 120 at itAt least partly expanded after longitudinal overlap and/or concentric position.Therefore, anchoring element 120 can be connected to valving members110, allow valving members 110 from opening with 120 longitudinal gap of anchoring element or the position of cascaded migration is moved to and anchorsAt least partly longitudinal overlap of element 120 or completely concentric position.
Anchoring element
As described above, anchoring element 120 may include various parts.For example, anchoring element 120 may include via flexibilityThe upper supporting piece 150 and lower support element 152 that connector 140 is linked together.Upper supporting piece 150, flexible connector 140 and lower branchSupport member 152 can provide the advantages of function and adaptability of mitral 100 and benefit.
Referring now to Fig. 7 A and Fig. 7 B, upper supporting piece 150 may include optionally having when observing in two-dimensional top-down viewThere is the structure of " D " shape (or ring with one or more straight flanges).Therefore, when observing in a top view, upper supporting piece 150 canTo include the rear portion 160 with semicircular in shape and the straight front 162 for being connected to rear portion 160.At geometric aspects, rear portion160 may include the circular portion of ring, and front 162 includes the end (opposed end at rear portion 160 in the circular portion of ring164,166) the string portion extended between, to generate the pingbian or straight flange of ring.
For example, upper supporting piece 150 may include the closure D-ring with release, opening or unfolded state, in the stateLower its can have approximate ellipsoidal shape or spherical form.When expanded, the radius of D-ring can be enough to the tissue in atrium sinistrumApply pressure and neighbouring self annulus of mitral valve.D-ring can take saddle type shape, to comply with the self annulus of mitral valve of health, andAnd the presence of the flat part of D-ring adapted under aorta-bicuspid valve every rigid structure.
Optionally, when expanded, the rear portion 160 of upper supporting piece 150 can be substantially flat, i.e., in the first planeExtend.Therefore, this section of upper supporting piece 150 extended between opposite end 164,166 can be located in the first plane.Here,Rear portion 160 can have first curvature radius.
In addition, the front 162 of upper supporting piece 150 can be optionally along the central axis 142 relative to valve prosthesis 100The axis bending being laterally extended leaves the first plane.For example, front 162 can be with the arch road between opposite end 164,166Radially it is bent.The bow-shaped route of front 162 may include circle one section or have second curvature radius.In some embodimentsIn, front 162 can extend in the second plane transverse to the first plane, then form bow-shaped route.For example, the second planeIt can be extended relative to the second plane with about 90 degree of angle, be prolonged relative to the second plane with about 20 degree to about 90 degree of angleIt stretches, is extended relative to the second plane with about 30 degree to about 80 degree of angle, relative to the second plane with about 40 degree to about 70 degreeAngle extends, or is extended relative to the second plane with about 50 degree to about 60 degree of angle.
In some embodiments, upper supporting piece 150 may include two, three or more engagement projection, which makesUpper supporting piece 150 can be disposed against annulus of mitral valve when in proper implantation heart.For example, in some embodiments, when expanded,Upper supporting piece 150 can optionally include three-dimensional " saddle shapes ".For example, upper supporting piece 150 may include rear protrusion 170 with beforeProtrusion 172.In addition, the saddle shapes of upper supporting piece 150 can also include from opposite end 164,166 in rear protrusion 170 with beforeThe lateral protrusion 174,176 extended between protrusion 172.When expanded, as shown in Figure 7 B, rear protrusion 170 and preceding protrusion 172 can phasesLateral protrusion 174,176 is bent upwards.In addition, lateral protrusion 174,176 can be relative to self annulus 80 (for example, phaseThe plane limited for mitral valve plane or by the vertex of point and rear protrusion 170 at opposite end 164,166) with about 25 degree extremelyAbout 55 degree of angle, about 30 degree to about 50 degree of angle or about 35 degree to about 45 degree of angle are extended downwardly from preceding protrusion 172.KnotFruit, preceding protrusion 172 can be configured to the atrial wall when being implanted into heart beside backup aorta, such as be pressed against aorta-Under bicuspid valve every.In addition, lateral protrusion 174,176 can be pressed against neighbouring annulus of mitral valve and the ventricle wall at annulus of mitral valve rear.Therefore, when in terms of side view as shown in Figure 7 B, upper supporting piece 150, which can have, can be configured such that and comply with self bicuspid valveThe saddle shapes of structure.
Therefore, the shape of upper supporting piece 150 can be designed to consistent with the anatomical structure of self annulus of mitral valve 80, and oneIn a little embodiments, anchoring element 120 can be anchored in bicuspid valve by lower support element 152, i.e., between left ventricle and atrium sinistrumHeart in.As shown in Figure 8 A, lower support element 152 may include the wire frame when seeing in a top view with circular shapeFrame body.Lower support element 152 may include: that multiple (such as two, three, four, or more) protrusions (are shown in the fig. 8bFor protrusion 180,182,184), upwardly extended along central axis 142；And multiple bonding parts, it can correspond to convexThe quantity in portion, such as two, three, four, or more (bonding part 190,192,194 is shown as in Fig. 8 A and Fig. 8 B),And between protrusion 180,182,184.Therefore, according to some embodiments, lower support element 152 may include two, threeOr more protrusion, when lower support element 152 is in expansion state, these protrusions extend so that each protrusion in left ventricleTissue applies pressure and neighbouring self annulus of mitral valve.
According to some embodiments, lower support element 152 may include the multiple joint elements 200 for being shown as hook structure,202,204, each joint element extends at corresponding one in multiple bonding parts 190,192,194 from lower support element 152.For example, lower support element 152 may include the one or more joint elements being located between two protrusions.Term " hook " or " hookStructure " is not intended to be limited to the shape or construction of hook element used herein.Term " hook " or " hook structure " can refer to following knotStructure: the structure can be attached to lower support element 152, and can be with radial dilatation, to contact or partially or even wholly be inserted intoTissue present in left ventricle and/or the tissue near bicuspid valve.Hook can be by shape memory metal or any biocompatibilityMaterial is made, and original appearance is kept in heart in several years after the implantation.Optionally, joint element 200,202,204 can be to permitPerhaps the mode that joint element 200,202,204 is engaged with the particular aspects of self mitral anatomy is separated from each other.In addition,Optionally, some or all of joint element or hook can be covered by fabric or suture material, to reduce or eliminate irritationWith the risk of cicatricial tissue accumulation (see, for example, Figure 10 A and Figure 10 B).
For example, in some embodiments, lower support element 152 may include three protrusions and three hooks.First hook 200 can be withIt is located between the first protrusion and the second protrusion 180,182.Second hook 202 can be positioned so that it is opposite with the first hook 200 and bySecond protrusion 182 separates.Optionally, third hook 204 can be positioned between the first hook 200 and second hook 202, the first protrusionBetween 180 and third protrusion 184.
According to some embodiments, each of hook 200,202,204 can prolong below the plane of lower support element 152Stretch, and when below annulus of mitral valve the left ventricular internal diameter of heart to when expansion towards annulus to rising to the bait.For example, in some realitiesIt applies in example, hook can be engaged with annulus of mitral valve, papillary muscle and/or ventricle wall, lower support element 152 is further anchored at a left sideIn heart between ventricle and atrium sinistrum.Each hook can be substantially distally extending, so that when being implanted into self annulus, hookIt is directed toward the direction opposite with blood flow in free end.However, in some embodiments, the free end of hook may point to the direction of blood flow.Hook200, it 202,204 may each comprise self-expanding shape-memory material, and be positioned so as to hook 200,202,204 and self two pointStructure engagement in valve or left ventricle (including left ventricular wall).In some embodiments, lower support element 152 may include more than threeA hook is positioned so as to hook and engages with the structure in self bicuspid valve or left ventricle (including left ventricular wall).In some implementationsIn example, since the hook 200,202,204 of lower support element 152 can be expanded during valve prosthesis delivers towards chordae tendineae, so theyUsing the design of shape memory metal allow them between chordae tendineae and/or around expand and hook.Optionally, in valve prosthesisDuring delivering, the hook of lower support element 152 can be pulled towards chordae tendineae, they allow them in tendon using the design of shape memory metalBetween rope and/or surrounding is hooked.
Upper supporting piece 150 and lower support element 152 can be made of shape-memory material (for example, Nitinol wire rod), the shapeShape memory material is sufficiently flexible to determine during implantation or in the rotational positioning of upper supporting piece 150 and lower support element 152 with lateralNative heart structure is complied with during position.For example, upper supporting piece 150 and lower support element 152 may each comprise self-expanding shape memoryWire rod.Wire rod can have range from the diameter of about X mm to Y mm.In some embodiments, upper supporting piece 150 and/or lower branchSupport member 152 may include two or more coilings, packaging material or metal loop.
Upper supporting piece 150 and lower support element 152 can be configured to provide enough radial forces and intensity to prevent or mostThe movement of smallization anchoring element 120, and in the embodiment using valving members, after being implanted into anchoring element 120, upper branchSupport member 150 and lower support element 152 can independently be expanded and be discharged into native valve.It is delivered to certainly by anchoring element 120After body annulus, upper supporting piece 150 can be deployed in atrium sinistrum intramedullary expansion, later, can be kept by upper supporting piece 150Lower support element 152 is pulled in left ventricle while in atrium sinistrum.After adjusting and discharging lower support element 152, upper supportTherefore part 150 is maintained in atrium sinistrum, and the holding of lower support element 152 is anchored in left ventricle.The structure of upper supporting piece 150 canTo assign anchoring element 120 little profile, so that being open when anchoring element 120 is released and is implanted into atrium sinistrum to pulmonary veinThe obstruction of (orifices of pulmonary veins) is minimum or does not block, however anatomic construction of the upper supporting piece 150 under its expansion or expansion stateOr shape can provide the pressure against atrial wall, to be enough to promote anchoring of the anchoring element 120 in self annulus of mitral valve.
It can be connected in referring again to Fig. 5 by flexible connector 140 with Fig. 6, upper supporting piece 150 and lower support element 152Together.According to some embodiments, flexible connector 140 may include one or more material chains or tubular skirt structure.For example,Fig. 5 and Fig. 6 are shown: flexible connector 140 may include upper supporting piece 150 and the lower end that upper end is connected to anchoring element 120It is connected to the fabric or Web materials (being shown as " skirt section " or tapered tubular component) of the lower support element 152 of anchoring element 120.It is softProperty connector 140 elasticity, stretchable flexible connection can be provided between upper supporting piece 150 and lower support element 152, this canTo promote the alignment between upper supporting piece 150 and the various aspects of lower support element 152, and for subtracting after completing implantation processIt is light or prevent perivalvular leakage.In some embodiments, flexible connector 140 can include but is not limited to elastomeric textile, stainless steelAlloy, marmem, superelastic alloy, knitted fabric and/or suture material.
In some embodiments, the use of flexible connector 140 provides additional benefit: it allows using can be on a left sideThe individual upper supporting piece 150 and lower support element 152 for independently discharging and expanding in corresponding one in atrium and left ventricle.Such asFurther described herein, upper supporting piece 150 can discharge in atrium sinistrum, and when lower support element 152 is pulled downwardly into a left sideVentricle is simultaneously pulled down in left ventricle intramedullary expansion against annulus of mitral valve.Because upper supporting piece 150 is via flexible connector 140It is connected to lower support element 152, and can be released in some embodiments independently of lower support element 152, it is possible underRotary alignment of the upper supporting piece 150 relative to annulus of mitral valve, lower support element 152 are more easily adjusted before the expansion of supporting element 152Connected structure may tend to limitation anchoring element 120 rotation adjust.Hereafter, flexible connector 140 may tend in upper branchApply the chronic power of collapsing between support member 150 and lower support element 152, this may cause upper supporting piece 150 and lower support element 152 is long-termIt is biased towards each other, to enhance the engagement of both upper supporting piece 150 and lower support element 152 with mitral anatomy.
Optionally, when being connected to flexible connector 140, the various aspects of upper supporting piece 150 and lower support element 152 can beIt is rotatably aligned relative to each other under the default setting of expansion.According to such embodiment, if upper supporting piece 150 and lower support element152 rotate relative to each other from default setting, then this movement will lead to tension and tensile stress is applied to flexible connector 140On.Therefore, if upper supporting piece 150 and lower support element 152 rotate in either direction relative to each other around central axis 142,Then flexible connector 140 will be released by the way that upper supporting piece 150 and lower support element 152 are realigned the alignment under default settingPut distorting stress.Therefore, during delivering anchoring element 120, if upper supporting piece 150 and lower support element 152 are relative to each otherRotation, then they may tend to realign relative to each other.In addition, according to some embodiments, upper supporting piece 150 and lower supportRelative positioning of the various aspects of part 152 under default setting can be structured as ensuring: when the adjusting upper supporting piece 150 during deliveringWhen with the position of one of lower support element 152 or another one, the various aspects of upper supporting piece 150 and lower support element 152 tend to phaseMitral anatomy is correctly positioned.
For example, as shown in Figure 5 and Figure 6, under default setting, the opposite end 164,166 of upper supporting piece 150 can be underThe hook 200,202 of supporting element 152 is rotatably aligned.Therefore, as discussed above, current protrusion 172 and aorta-bicuspid valveUnder when alignment, hook 200,202 may tend to engage with the tissue immediately below preceding inside commissure 88 and rear outside commissure 86.For example, in some embodiments, preceding protrusion 172 (being illustrated as extending through plane in the vertical view of Fig. 7 A) can be activelyThe line or plane (for example, as shown in dotted line 92 in Fig. 4) of arteries and veins-bicuspid valve 92 less than 20 degree in the range of, less than 15 degreeIn range, less than 12 degree in the range of, less than 10 degree in the range of, less than 8 degree in the range of or less than 5 degree in the range of it is rightIt is quasi-.Therefore, in some embodiments, the plane of the flat surface of preceding protrusion 172 can fall in the plane of aorta-bicuspid valve 92In the range of about 10 degree, with prosthese 100 and around valve structure between satisfactory sealing is provided.
In addition, according to some embodiments, flexible connector 140 can provide fluid-impermeable sealing, to be implanted intoMitigate or prevent perivalvular leakage after the completion of operation.As described above, flexible connector 140 may include in upper supporting piece 150 and lower branchThe fabric skirt being extended continuously between the circumference of support member 152 with surrounding.Therefore, when upper supporting piece 150 and lower support element 152 are securedGround fastening and when against self mitral structure, flexible connector 140 can tend to ensure that: in addition to be passed through it is flexible evenExcept the blood flow for connecing the inner cavity in device 140 itself, other blood flows will not occur.Therefore, when valving members in some embodiments110 in the interior endoluminal expansion of flexible connector 140, and blood will flow through mitral 100, to avoid perivalvular leakage.
In addition, according to some embodiments, anchoring element 120 can be implanted into the patient, without being subsequently implanted valve portionPart, so that complex executes the functionally similar function with annuloplasty ring.
The loop design of the anchoring element 120 of some embodiments disclosed herein advantageouslys allow for anchoring element 120 canIt is delivered to intracorporal target position, is reliably disengaged with delivery system, and is securely engaged with annulus of mitral valve.ApplicantThe anchoring element for much studying and testing many generations has been carried out.Various initial designs are the super-elasticity using different-thicknessNitinol wire rod shapes.However, regardless of the variation of early stage, in delivering of the anchoring element from delivery system and separation sideFace still has many problems.Finally, developing loop design.Loop design realizes function identical with other initial designsCan, but eliminate many problems encountered.
For example, upper supporting piece (or " apical ring ") can comply with self saddle-shaped ring, sealed with being formed with the internal membrane of heart, and from the heartRoom side forms anchoring piece.Upper supporting piece can be made of shape of 0.020 " Nitinol wire rod.Upper supporting piece may include " D "Shape Nitinol structure.Lower support element (or " base ring ") may include another Nitinol ring for being formed with hook thereon.Lower support elementUpper supporting piece can be connected to via flexible connector or tubular skirt.Three hooks of lower support element can be separated by about 120Degree positioning, with lock card in two commissures and P2 segment of native valve, to create anchor point from ventricular side.Upper supporting pieceIt can be connected via tubular skirt with lower support element.
In some embodiments, during delivering, upper supporting piece will be by the grasper of delivery system or support with bolting partConstraint, therefore upper supporting piece is allowed more fully to open can have bigger than lower support element straight and in some embodimentsDiameter or size.Because upper supporting piece can be opened more fully, anchoring element can be provided against the reliable of annulus of mitral valveCooperation, so as to improve sealing.Anchoring element is pulled while against annulus of mitral valve to nearside in doctor, this can also improveThe anchoring ability of upper supporting piece.Further, since two rings of anchoring element are separated by flexible skirt connector, so they can be withIndependently working, (for example, upper supporting piece can fully open, and lower support element can be manipulated and it is allowed to expand and anchorOn self mitral valve apparatus).In addition, when in terms of axial visual angle, the valving members of the circular shape of valve prosthesis in implantationSurrounding generates sealing.In various tests, the tissue model harvested is used for workbench test (benchtop testing),In the form of verifying and optimize these features and function.
In addition, in some embodiments, the crown of lower support element is designed to be crimped onto delivery sheath in an uniform mannerIn.During implantation, upper supporting piece can be unfolded in atrium first before positioning and discharging lower support element.This two-stepIt opens relatively reliable, and is more easily controlled.Arch on the flat surfaces of upper supporting piece can advantageously allow for upper supporting piece suitableThe variation of the size and shape of patient's annulus is answered, while being still maintained and endocardial sealing.
Finally, connecting the tubular skirt of two sub-components for several crucial purposes according to some embodiments.From upper branchThe tension of fabric in support member and lower support element ensures that anchoring piece locking is in place and will not move after the implants.From fabricSo that hook is slid into its predetermined anchor point with the slight elasticity of autologous tissue, then rebounds in place to lock.In addition, tubular skirt may be used alsoFor use as the hemostasis seal for surrounding artificial valve, to reduce perivalvular leakage and promote to grow in meat after implanted device.
Valving members
As described above, in some embodiments, mitral 100 may include anchoring element 120 and valving members110.Valving members 110 may include in United States Patent (USP) No.8,444,689, No.8,540,767, No.8,366,768, No.8,Any valving members disclosed in 366,767 or U.S. Patent application No.US 2014/0052240, each above-mentioned patent it is completePortion's content is hereby incorporated herein by；In addition, according to some embodiments, disclosed in operation method can be used for delivering thisAny valve prosthesis disclosed in text.
As shown in figure 5, valving members 110 may include expansible valve frame 210, artificial leaflet can be attached to valveFrame 210, such as it is attached to the inner surface of valve frame 210.Valve frame 210 can with radial dilatation at tubular form, whereinCross section be it is circular, there is outer surface or outer surface and limit central lobe mouth around axis (longitudinal axis).Longitudinal axis pairIt should be in inflow-outflow axis.Valve frame 210 can be made of self-expanding shape memory metal.Valve frame may include netThe tubular material of shape or braiding is cut by laser to obtain from tubular material.In some embodiments, metal is Nitinol.CanIt selects in embodiment, valve frame 210 may include non-self-expanding material, but can be expanded by individual component, such as logicalIt crosses and uses foley's tube.
There may be the multiple artificial leaflets for being attached to inner surface, each artificial leaflet is fabricated from a flexible material, flexible materialMaterial imitates the anatomical structure and physiological function of native heart leaflet.In some embodiments, two or three artificial leaflet attachmentsTo inner surface.Artificial leaflet may include the material for the group for selecting freeman, ox, pig or horse pericardial tissue composition or come from people, oxOr the aortic root of pig.Alternatively, artificial leaflet may include biocompatible polymeric material.Therefore, valve can beXenograft or alloplast.If such as may be beneficial with glutaraldehyde processing material to improve biocompatibility's.Biocompatible materials as valve replacement object are usually molten by the way that material is fixed on the glutaraldehyde as tissue preservativeIt is manufactured in liquid.Although the fixation in glutaraldehyde might mean that the shortcomings that biomaterial calcification, glutaraldehyde fixation is stillIt saves tissue and prepares tissue and be used to be implanted into the selection method as biomaterial.In this respect, if with the object for preventing calcificationMatter (such as with dimethyl sulfoxide or the like) processing valving members, then may be beneficial.
Valving members 110 may include circular cross section, can permit attached artificial leaflet and is connected to thereon.ValveFilm frame 210 can also include multiple spines or barb on its outer surface.When heart is received during its normal physiological functionWhen contracting, this barb facilitates the movement that the valving members of implantation are anchored in heart and are prevented the prosthese of implantation.Work as presenceWhen barb, barb can be made of self-expanding shape-memory material, and therefore can use compact or expansion state.For example,When valving members 110 expose and allow to expand during deployment, barb can also be expanded with up and out and/or downwardsIt is prominent.
Valving members 110 may include the linings such as fabric or mesh blanket or covering, can be attached to valveThe outer surface of film frame 210 and/or inner surface.In some embodiments, covering can be impermeable blood or other fluids.
In Fig. 5-Fig. 6 (valving members 110), Figure 10 A- Figure 10 C (valving members 252) and Figure 11 A and Figure 11 B (valveComponent 360) in show the embodiment of valving members for mitral as described herein.
Connection between anchoring element and valving members
In some embodiments using both anchoring element and valving members, anchoring element 120 may include and valveThe separation of component 110 and/or the structure that can be expanded independently of valving members 110.In such embodiments, anchoring element 120 and valveThe interconnection of coupler component 122 can be used in membrane element 110, and coupler component 122 can be in anchoring element 120 and valving membersA certain range of free relative motion is provided between 110.In some embodiments, coupler component 122 can be connected to branchSupport member 150 and/or lower support element 152.
Referring again to FIGS. 5, coupler component 122 may include one or more linear structures.In some embodiments, joinConnecing device component 122 may include one or more suture.For example, in some embodiments, coupler component 122 may includeOne, two, three or more linear structure, filament or fiber, such as suture.Coupler component 122 may include threeRoot suture, wherein the first end of every suture is attached to anchoring element 120, and the second end of every suture is attached toThe valve frame 210 of valving members 110.In some embodiments, when there are two or more sutures, suture intervalOpen equidistance.Since coupler component 122 produces the interconnection between valving members 110 and anchoring element 120, work asWhen pulling in nearside or distal direction, largest interval or distance between valving members 110 and anchoring element 120 can at least portionsGround is divided to be determined by the length of coupler component 122.
In Fig. 5, coupler component 122 is shown as silk thread 124a, 124b, 124c.For example, coupler component 122 canTo include one or more suture, every suture is connected to anchoring element 120 in its first end, and connects in its second endIt is connected to valving members 110.In an alternative embodiment, coupler component includes compliant member, such as is attached to 120 He of anchoring elementA fabric or net on valving members 110.For example, in some embodiments, coupler component 122 is fluid-tight continuousMaterial can prevent perivalvular leakage after implantation anchoring element 120 and valve prosthesis 100.
According to some embodiments, coupler component 122 can have regular length, which determines anchoring elementThe range of 120 longitudinal directions or rotary motion that can have relative to valving members 110.For example, anchoring element 120 can be along centerAxis 142 is (related to inflow-outflow axis when being present in self annulus) mobile, allows it along longitudinal axis with such asLower distance and valving members 110 separate: the distance be valving members 110 length about 10% to 100%, 25% to 75%,33% to 100%, 33% to 66%, 25% to 75% or 50% to 75% or 60% to 70%.Anchoring element 120 can be along10% to 100%, 25% to 75%, the 33% of the length of its longitudinal axis valving members 110 Chong Die with valving members 110 to100%, 33% to 66%, 25% to 75% or 50% to 75%.
Coupler component 122 can permit rotary motion of the anchoring element relative to valving members 110.Therefore, although depositingIn coupler component 122, but anchoring element can rotatably be moved relative to valving members 110.In some embodiments, coupleDevice component 122 can be rotated freely when valving members 110 keep stablizing around central axis 142, wherein rotate freely rangeIn about 180 degree between about 460 degree, in about 180 degree between about 360 degree, in about 180 degree between about 340 degree, about 180Degree is between about 300 degree, in about 180 degree between about 280 degree, or in about 180 degree between about 260 degree.
Optionally, valving members 110 are allowed more to hold the flexible material that anchoring element 120 is connected to coupler component 122It changes places in the inner cavity of anchoring element 120 alignment or the lumens aligned relative to anchoring element 120.In addition, in some embodimentsIn, coupler component 122 can make valving members 110 be more easily positioned at anchoring element 120 upper supporting piece 150 and lower branchIn the circumference of support member 152.Coupler component 122 can also allow for valving members 110 to be maintained at along longitudinal axis 142 and anchor memberPart 120 is adjacent or continuous fore-and-aft distance in.For example, before and during anchoring element 120 is delivered to self annulus of mitral valve,Upper supporting piece 150 can be released and be located in the nearside of valving members 110.When valving members 110 are located in anchoring elementWhen in circumference, such as when anchoring element 120 discharges in self annulus, coupler component 122 can to valving members 110It is limited with applying with both anchoring element 120 is separated by a distance and valving members 110 are relative to anchoring element 120 positionsSystem.
Coupler component 122 between valving members 110 and anchoring element 120 is for allowing valve prosthesis 100 having needIn the self annulus of mitral valve of the patient wanted it is compact and effective delivering and open extremely important.Specifically, being delivered to certainlyDuring body annulus and before its opening, anchoring element 120 and valving members 110 can be positioned continuously or longitudinally of one anotherIt is spaced apart.In some embodiments, such as when valve prosthesis 100 is in during passing through blood vessel or other openings are delivered to heartWhen its compact condition, the permission system that is not overlapped during proceeding to target position between the two has smaller diameter.In addition,Some embodiments of valve prosthesis 100 allow anchoring element 120 in self annulus independently of valving members 110 and in valve portion(release or expansion) is opened before the positioning and opening of part 110 and is positioned.
In some embodiments, coupler component 122 may include tubular structure, such as fabric pipe.Coupler component 122Tubular structure can limit first end, which can be fastened or connected to anchoring element 120 along its entire edgeIn whole circumference.Coupler component 122 can limit the second end for being fastened or connected to valving members 110.Second end can beBe connected to valve frame 210 at following position: the position make attached fabric cover valving members 110 about four/One, one third, half, 2/3rds or 3/4ths or a quarter are to any range between 3/4ths.In an alternative embodiment, the second end of fabric can be connected at the following location valve frame 210: the position makes attachedFabric covering valving members 110 whole surface.Alternatively, the second end of fabric could attach to valving members 110 mostClose to the end of anchoring element 120, so that valving members 110 are not connected device fabric and cover along its side.Work as coupler componentWhen 122 fabric does not cover valving members 110, there may be all or part of individual textile-likes of covering valve frameMaterial.This individual web form materials can be minimized or prevent leakage (perivalvular leakage) of the blood across valving members 110.
In some embodiments, the fabric of coupler component 122 can be made of flexible fabric shape material.The material can be withIt is made of such as polyester polymers.It is used herein for for anchoring element 120 being flexibly coupled to the fabric of valving members 110It is commonly known in the art, and may include bio-compatible and be suitable as Support frame " sheath " it is any fromBody or synthetic polymer.In addition, polymer can use medicinal actives substance or any other coating substance, to influence and/or controlTreat the state of an illness of 100 implant site of prosthese of patient.Medicinal actives substance can for example prevent narrow, acceleration treatment blood vesselWound or the development for preventing inflammation.In addition, anchoring element 120 and/or valving members 110 can with medicinal actives coating substance orProcessing.In some embodiments, fabric can be porous, to allow the blood during valve prosthesis implantation process to flow through and knitObject.
Referring now to Fig. 9 A and Fig. 9 B, the alternative embodiment of anchoring element 120 may include filling component or skirt section 230.Figure9A shows the perspective view of anchoring element 120 and filling component 230, and Fig. 9 B shows facing upward for anchoring element 120 and filling component 230View.
According to some embodiments, filling component 230 can be advantageously used for packing material, when prosthese 100 is located in patient's bodyWhen interior, which occupies any gap between annulus of mitral valve and anchoring element 120, to enable filling component 230As the device for reducing perivalvular leakage.In addition, filling component 230 can also improve the anchoring of valve prosthesis (for example, by ventricleValve valve is served as during contraction).
Filling component 230 can be connected to anchor part 120 along the upper area of anchor part 120.For example, filling partThe upper area 232 of part 230 can be attached to a part of upper supporting piece 150 or flexible connector 140.Filling component 230Lower end area 234 can be upwardly away from upper area 232 in the side towards lower support element 152 and extend.Lower end area 234 can encloseCircumference around lower support element 152 extends.In some embodiments, lower end area 234 can extend down through lower support element 152Lower ranges.However, lower end area 234 also extends to the position between upper supporting piece 150 and lower support element 152It sets.
Filling component 230 can be used herein in regard to any disclosed in flexible connector 140 and/or coupler component 122Material is formed as tubular part.In some embodiments, filling component 230 can be (such as poly- by flexible fabric or Web materialsEster polymer) it is made.In some embodiments, fabric can be porous, to allow the blood during valve prosthesis implantation processLiquid stream crosses fabric.Alternatively, filling component 230 may include that can partially or completely prevent blood penetration from passing through filling component230 web form materials.In some embodiments, filling component 230 may include that shape memory flexible material (such as uses NiTiThe fabric of promise yarn woven), to help Forming Connection device component 122.In addition, filling component 230 can use medicinal actives substanceOr any other coating substance, to influence and/or treat the state of an illness of 100 implant site of prosthese of patient.Medicinal actives substance canFor example to prevent the development of narrow, accelerating wound healing or prevention of inflammation.
Advantageously, according to some embodiments disclosed herein, valving members can be the component separated with anchoring element,And anchoring element can be flexibly attached to via connector.Therefore, such embodiment makes anchoring element and valving membersIt can be implanted into two individually operation.
Mitral including single anchoring ring
Figure 10 A and Figure 10 B show the valve prosthesis 250 including valving members 252 and anchoring element 254, wherein anchoringElement 254 includes single anchoring ring 256.Anchoring ring 256 may include preceding protrusion 260, rear protrusion 262 and hook as described above264,266,268.Valving members 252 and anchoring ring 256 are self-expanding structure.It is installed on the inner surface of valving members 252There are multiple artificial leaflet (not shown).Figure 10 A shows valving members 252 and anchoring ring 256 along longitudinal axis in series with each otherDeviate.Although Figure 10 A is shown in unfolded or expansion state valving members 252 and anchoring ring 256, in valve vacationDuring the actual delivery of body, valving members 252 and anchoring ring 256 may be at compact condition, until anchoring ring 256 is released,This will more fully hereinafter be described.
Figure 10 A shows the embodiment of the anchoring ring 256 on expansion state and circumferential direction with valving members 252, anchorGu ring 256 includes rear protrusion 262 and preceding protrusion 260, wherein the first hook 264 and second hook 266 are located in rear protrusion 262 and lordosisRecess between portion 260.May exist third hook 268 in some embodiments, the centre of rear protrusion 262 can be located at.The embodiment of coupler component 270 is shown in Figure 10 A- Figure 10 C, wherein coupler component 270 includes being attached to anchoring ring256 and 252 the two of valving members on tubing.When valve prosthesis 250 is located in self annulus, anchoring ring 256 canTo be located in the outside of valving members 252 so that anchoring ring 256 around valving members 252 and partially or completely with valveComponent 252 is with one heart (as shown in figs. 10B and 10C).Figure 10 A and Figure 10 B also show some or all of hook 264,266,268It can be covered with fabric or suture material 272, to reduce or eliminate the risk of irritation and cicatricial tissue accumulation.
Figure 10 C depicts the left side from the mitral 250 being located in native valve structure 280 that atrium sinistrum is seen down intoThe top view of ventricle.Before anchoring ring 256 can discharge in self annulus 280 and deenergized period is flexibly coupled to valve portionPart 252.However, upon discharge, hook 264,266,268 can be located at self 280 lower section of annulus, and preceding protrusion 260 and rear convexPortion 262 can be located at self 280 top (in atrium sinistrum) of annulus, and valving members 252 are fully expanded in radial directions.Valving members 252 in 256 intramedullary expansion of anchoring ring and can be connected to anchoring ring 256, motionless to be held stationary relative to each other,To allow valve prosthesis 250 to keep substantially fixed motionless relative to self annulus.Therefore, when heart pump blood and bloodWhen flowing through mitral 250, the prosthese leaflet of valving members 252 can be moved as the native valve of health, but still be protectedIt holds and is located in self annulus 280.
The delivery system of mitral
There is also described herein being delivered for such as mitral through the apex of the heart or the delivery system through catheter delivery.DeliveringSystem can support valve prosthesis, wherein delivery apparatus includes the first sheath, the second sheath and control unit, wherein the first shieldIt covers in the distal side of the second sheath, and the second sheath is in the distal side of control unit.In some embodiments, the first sheath may includeTapered end.First sheath and the second sheath can be before and during valve prosthesis deliver at least partially around valving membersAnd anchoring element.It should be appreciated that construction of the delivery system relative to the first sheath and the second sheath, valving members and anchoring elementCan be following any construction: the construction allows during delivering anchoring element and valving members with compact condition along longitudinal axisLocated in series, and then position and discharge valving members before independently release and positioning and anchoring element, this will hereafter more in detailCarefully describe.
Referring now to Figure 11 A- Figure 11 C, the delivering for delivering and discharging valve prosthesis 302 as described herein is shownThe embodiment of system 300.Delivery apparatus includes the first sheath 310 and the second sheath 320 positioned at 310 nearside of the first sheath.TheTwo sheaths 320 are located at the distal side of control unit (not shown), and doctor controls the various portions of delivery system 300 by control unitPart.Valve prosthesis is being delivered to the intracorporal target position of body (for example, being discussed and the be shown as herein annulus of mitral valve) phaseBetween, the first sheath 310 and the second sheath 320 can accommodate valve prosthesis 302 together.
Figure 11 A shows the structure of the delivery system 300 before the delivering before discharging valve prosthesis 302 and during deliveringIt makes.Valve prosthesis 302 can be configured to include valve prosthesis 100 or valve prosthesis 250 as discussed above feature.Figure 11 BShow during delivering but after release anchoring element 304 (such as anchoring element 120) and release valving members (such asValving members 110) before identical delivery system 300 construction.
According to some embodiments, as seen in figs. 11a and 11b, delivery system 300 may include extending through the first sheath310 and second sheath 320 center length central axis 330.The distal end of central axis 330 can be attached to the first sheath 310Inner surface so that by the longitudinal movement (for example, by pushing or pull on central axis 330) of control centre's axis 330, Yi ShengkeLongitudinal movement to control the first sheath 310 in a manner of independently of the second sheath 320, to enable the first sheath 310It is mobile relative to the second sheath 320.In some embodiments, for the ease of system 300 is delivered to target position, central axis330 can be configured to allow for system 300 to move along seal wire 340, and seal wire 340 can extend through the center of central axis 330Length.
Delivery system 300 can optionally include the reversed cone or valve of the far-end positioned at valve control pipeline 345Seat 350.Valve seat 350 may include a pair of discs, this is spaced apart disk along longitudinal axis and controls inner cavity by valveOr pipeline 345 interconnects.Valve seat 350 can provide position or space, during delivering and the component of sheath and prosthese itBetween relative motion during, the valving members collapsed can be supported in the position or in space.The end surfaces of reversed cone 350Anchoring element and/or valving members can be abutted, and anchoring element and/or valving members are maintained at first during deliveringIn one or both of sheath or the second sheath.Valve seat 350 can dissolve the first sheath or cone during loading and deliveringThe frictional force of valving members in body.It is single that valve control pipeline 345 can be attached to control in the proximal end of delivery system 300Member extends through the center of the second sheath 320, and terminates at valve seat 350.
As seen in figs. 11a and 11b, delivery system 300 may include at least one grasper or support with bolting casing395a, 395b or 395c.The quantity of support with bolting casing is preferably equivalent to the joint element of anchoring element 304 or the quantity of hook(for example, quantity of the joint element of the lower support element such as in valve prosthesis 100).Each support with bolting casing 395a, 395bControl unit can be connected in place at its proximal end with 395c.The distal end of each support with bolting casing 395a, 395b and 395c can be withOn the hook for surrounding or being connected to anchoring element 304.The distal end of support with bolting casing 395a, 395b and 395c and anchoring element 304Joint element between interconnection can permit the anchoring element 304 of valve prosthesis 302 relative to the second sheath 320 or secondFixed and/or collapsed position is maintained in sheath 320.When the second sheath 320 is relative to support with bolting casing 395a, 395bWhen with the distal end of 395c along proximal retraction, as anchoring element 304 is expanded, the joint element of anchoring element 304 can be from anchoringControl the distal end release of casing 395a, 395b and 395c.Therefore, doctor can control the longitudinal movement of support with bolting casing, withInfluence the longitudinal movement of anchoring element 304.
In some embodiments of delivery system 300, as shown in Figure 11 A, it can be released to self by valving members 360Before in annulus, the valving members 360 of valve prosthesis 302 are enclosed in the first sheath 310.Release anchoring element 304 itBefore, anchoring element 304 can be closed in the second sheath 320 (for example, the distal end for passing through the second sheath 320).Although Figure 11 BThe anchoring element 304 including D-ring 370 and anchoring skirt section 380 (such as showing in fig. 5 and fig.) has been shown in particular, but hasThe valve prosthesis delivery system 300 that constructs shown in Figure 11 A- Figure 11 C can be used such as to be discussed in Figure 10 A- Figure 10 C aboveAnchoring element carrys out work.
In the alternative embodiment of delivery system 300, before discharging anchoring element 304, before delivering and delivery periodBetween, both anchoring element 304 and valving members 360 can be closed in the second sheath 320.For example, in some embodimentsIn, anchoring element 304 can be located at the distal side of valving members 360, wherein anchoring element 304 is remote close to the second sheath 320End, and valving members 360 can be with generally adjacent anchoring element 304 (being in series configuration) and positioned at the close of anchoring element 304Side.In some embodiments of delivery system 300, both anchoring element 304 and valving members 360 can be enclosed in the second shieldIn set 320, wherein valving members 360 are close to the distal end of the second sheath 320, and the generally adjacent valving members of anchoring element 304360 and be located at valving members 360 nearside.
In some embodiments of delivery system, before and during delivering valve prosthesis 302, anchoring element 304 can be withIt is enclosed in the first sheath 310, and valving members 360 can be enclosed in the second sheath 320.For example, in delivery systemIn 300 some embodiments, both anchoring element 304 and valving members 360 can be closed in the first sheath 310, andAnd valving members 360 can be closed in the second sheath 320 before and during delivering valve prosthesis 302.In this configuration,Anchoring element 304 and valving members 360 can (being in series configuration) generally adjacent to one another, and anchoring element 304 can be determinedNearside of the position in valving members 360.
In any of above construction of delivery system 300, doctor can independently discharge anchoring element 304 and valving members360.Anchor part 304 can be discharged before discharging valving members 360.
In addition, anchoring element 304 can be optionally deployed in self in any of above construction of delivery system 300Annulus is manipulated after nearby.For example, after discharging anchoring element 304 from delivery system 300, each of anchoring element 304Hook releasedly or can be reversibly attached to support with bolting casing 395a, 395b and 395c (for example, hook is by support with bolting casing395a, 395b and 395c closing), and doctor can move anchoring element 304 along rotation axis or longitudinal axis, so as to fixedAnchoring element 304 is appropriately positioned in self annulus before position and release valving members 360.
Before discharging valve prosthesis 302, i.e., before and during being delivered to native valve site, 304 He of anchoring elementValving members 360 can be located adjacent to along the longitudinal axis of delivery system 300.The construction is (opposite with arranged concentric) to be permittedPerhaps two components more compact construction in the radial direction of valve prosthesis 302, consequently facilitating delivering catheter-based.
As discussed herein in regard to other embodiments, as seen in figs. 11a and 11b, anchoring element 304 and valving members360 can flexibly be connected by least one coupler component 352.Coupler component 352 can be configured to be as described aboveCoupler component 122.For example, coupler component 352 may include being connectable to anchoring element 304 and valving members 360The suture of the two or other flexible chords.In some embodiments, a side end of coupler component 352 can be attached toFixation position on anchoring element 304, and end side can be attached to the fixation position on valving members 360.SomeIn embodiment, only a side end of coupler component 352 is attached to the fixed bit on anchoring element 304 or on valving members 360It sets.In addition, in some embodiments, coupler component 352 may include rings of material or material strips, the rings of material or material strips are softProperty connect valving members 360 and anchoring element 304, without being tied on or being fixed on valving members 360 or anchoring element 304Single location.In some embodiments, the coupler component 352 between anchoring element 304 and valving members 360 may includeTextile material, such as fabric pipe (see, for example, Figure 10 A and Figure 10 B).
Coupler component 352 may include valving members 360 use and can be along longitudinal axis relative to anchoring element 304Any device that is mobile while limiting the maximum vertical move distance between valving members 360 and anchoring element 304.In some realitiesIt applies in example, doctor can make the distance between anchoring element 304 and valving members 360 reach maximum, so that valving members 360 are fixedNearside or distal side of the position in anchoring element 304.When coupler component 352 is in the tight position, doctor can apply additionallyLongitudinal force and lightly pull anchoring element 304 along nearside or distal direction, to adjust anchoring element 304 in native valvePosition.Anchoring element 304, which may be positioned such that, is bonded on the protrusion of its lower support element and hook in left ventricle, and upper supporting pieceOr D ring is located in atrium sinistrum.When anchoring element 304 includes such as the anchoring ring described in Figure 10 A- Figure 10 C above, in hookIn the case where the two opposite sides of annulus, anchoring element 304 be can be positioned in native valve, so that hook is located at left ventricleIn, and protrusion is located in atrium sinistrum.When anchoring element 304 has been properly positioned in self annulus, it is enclosed in firstValving members 360 in sheath 310 or the second sheath 320 can be along longitudinal axis towards the inner cavity of anchoring element 304 or and anchorGu the interior intracavitary position of 304 longitudinal overlap of element is mobile and is moved to the position.In some embodiments, anchoring element 304It may be positioned such that at least partially or fully concentric with valving members 360.Therefore, when by the valving members of valve prosthesis 302360 when being located in self annulus, and valving members 360 can have the fixation motion range along longitudinal axis.In addition, by mentioningFor having the flexible connection of the fixed motion range calculated along longitudinal axis, doctor is known that anchoring element 304 and valveWhen membrane element 360 is separated from each other or is properly located relative to each other.In some embodiments, anchoring element 304 byAfter coupler component 352 cannot be moved further, anchoring element 304 and valving members 360 are suitably fixed relative to each otherPosition, and valving members 360 can be discharged.
In addition, anchoring element 304 can be while valving members 360 keep stablizing around certainly according to some embodimentsThe rotation axis of body moves freely.This rotate freely can be from sheath release and due to the flexible nature of anchoring element 304Occur before expansion and later.Protrusion and hook can work together, and anchoring element 304 is stabilized in self annulus.ExampleSuch as, after release anchoring element 304 expands it in atrium sinistrum in sheath, doctor can longitudinally and rotationally be movedDynamic anchoring element 304, until anchoring element 304 appropriate protrusion (for example, as described above, the D-ring observed from top it is straightSide) it is suitably positioned at the atria portion of annulus of mitral valve, for example, every alignment under straight flange and aorta-bicuspid valve.
After discharging anchoring element 304, the hook of anchoring element 304 and/or protrusion can expand and be drawn to acrossThe position (or be pulled through annulus and expand) of annulus, to allow to connect with structures such as papillary muscles in left ventricleTouching.At this point, before discharging valving members 360, the construction of anchoring element 304 and positioning can prevent anchor in implantation processGu element 304 is towards the movement of left ventricle or atrium sinistrum.For example, when anchoring element 304 includes D-ring shape upper supporting piece, onSupporting element can reduce and/or prevent anchoring element 304 further towards the migration of left ventricle, and lower support element can be reducedAnd/or prevent migration of the anchoring element 304 towards atrium sinistrum.Protrusion when anchoring element 304 includes anchoring ring, in atrium sinistrumAnchoring element 304 can be prevented further towards the movement of left ventricle, and the hook in left ventricle can prevent 304 court of anchoring elementMovement to atrium sinistrum.
In some embodiments, delivery system 300 can deliver not include valving members prosthese.With anchoring element butDelivery system without valve prosthesis can be only used for delivering and being implanted into anchoring element, can be similar with annuloplasty ringIt works on ground.
In some embodiments, delivery system 300 can deliver not include anchoring element prosthese.Therefore, to twoThe treatment of the patient of cusp disease may include delivering and being implanted into first anchoring element as described herein, remove delivery system,Then individually and successively deliver and be implanted into valving members.
Use the Using prosthesis of non-return valve
In some embodiments, delivery system can also include the non-return flap temporarily discharged during the delivering of valve prosthesisFilm.Specifically, non-return valve can be released and be maintained at after discharging anchoring element and before discharging valving membersExpansion state.At which in the period expanded, non-return valve can prevent the reflux of the blood during delivery process, fromAnd lead to the smaller pressure to patient's heart.After valving members are released in self annulus, non-return valve can be pressedIt contracts and is removed from patient using delivery apparatus.
For example, Figure 12 shows the delivery system for disposing non-return valve 400.Non-return valve 400 can be used in valveThe reflux of blood is minimized when self mitral leaflet cannot work due to there are delivery system during prosthesis delivery process.As shown in figure 12, non-return valve 400 may include non-return valve frame 410 and cover 420.Non-return valve frame 410 can be withIncluding self-expanding material and/or shape-memory material.In addition, non-return valve frame 410 can be connected to multiple non-return valve controlsPipeline 430a, 430b, 430c, these non-return valves control pipeline can be manipulated by doctor to control the release of non-return valve 400.ThisOutside, in some embodiments, cover 420 may include fluid-tight textile material.
Non-return valve 400 can be located in delivery system before and during delivering valve prosthesis with compact condition.OnlyReturning valve 400 can be enclosed in the first sheath 440 or the second sheath 450 of delivery system.In some embodiments, it is dischargingBefore anchoring element, non-return valve 400 can be closed in the second sheath 440.Non-return valve 400, which can be positioned so that, to be located atThe proximal and distal of the anchoring element in the second sheath 440 or concentric with anchoring element is enclosed in front of discharging anchoring element.?Discharge anchoring element after but before discharging valve frame, non-return valve frame 410 can be pushed along distal direction, with fromIt opens the distal end of the second sheath 440 and therefore expands, prevent blood reflux from passing through annulus of mitral valve so as to cause cover 420.
In some embodiments, each proximal end of non-return valve frame 410 can be connected to support with bolting casing (for example,Support with bolting casing 395a, 395b and 395c) distal end so that the opening of the anchoring element of non-return valve 400 and prosthese is substantiallyIt discharges simultaneously.
The method for being implanted into mitral
Use the method for any of implantation as described herein, delivering and valve prosthesis device implantation mitralIt can be changed according to used delivery routes and anchoring element, but all methods can be related to the minimally invasive of mitralProperty through catheter delivery and implantation, wherein with artificial leaflet self-expanding valving members be coupled device component be flexibly coupled toSelf-expanding anchoring element, and valving members and anchoring element are delivered with compact condition, wherein valving members and anchoring elementIt is positioned in series relative to each other along longitudinal axis.
Regardless of delivery routes, anchoring element can be by operation and again fixed independently of valving members after deploymentPosition, to ensure correctly to place.Mitral can be implanted on existing self mitral leaflet.It is fitted in anchoring elementAfter placement, valving members along longitudinal axis towards anchoring element move one section by the length of coupler component determine away fromFrom so that valving members are concentric with anchoring element, at this point, valving members can be released and remove delivery apparatus from patient.Carry out positioning and anchoring element in part with imagings such as ultrasonic imagings.In some embodiments, doctor can feel anchoring memberEngagement of the part in self annulus, in order to which anchoring element is along the appropriate positioning of the longitudinal axis of native valve.
The lesion for showing and discussing for mitral to be delivered in patient relative to Figure 13-Figure 17 is mitralSome embodiments of method, Figure 17 shows the methods for using delivery system 500 to deliver mitral 510 by Figure 13-.Ginseng aboveIt examines Figure 11 A- Figure 11 C and describes the various embodiments and feature of delivery system 500, and is no longer heavy herein for simplicityIt is multiple.
Figure 13-Figure 19 is shown through apex of the heart art, can be applied to any delivering method, wherein the distal end of delivery systemLeft ventricle 16 is advanced into be advanced through that bicuspid valve enters atrium sinistrum 18.As shown in figure 13, it is normally started from through apex of the heart artThe apex of the heart in left ventricle 16 punctures, and seal wire 504 is then introduced through self bicuspid valve 32 and at least enters atrium sinistrum 18.DeliveringThe guide or trochar that the distal end of system 500 (valve prosthesis 510 is closed in wherein) is disposed through in ventricle wall are introduced intoInto left ventricle 16, to generate the open approach for leading to bicuspid valve 32.However, in some embodiments, other can be used and passsSend path.For example, the distal end of device can be introduced into the femoral artery of patient, and passed through femoral artery and proceeded to aorta, wearIt crosses aorta petal and enters left ventricle 16, then pass through bicuspid valve 32 and enter atrium sinistrum 18.
Delivery apparatus 506 may include the first sheath 520, the second sheath 530 and grasper or support with bolting part 550.TheOne sheath 520 can be connected to the tubular part 522 that can extend through the second sheath 530.In addition, tubular part 522 can be withIncluding guidewire lumen, which is configured to allow for system 500 to slide into target area along seal wire 504.Prosthese 510 can be withIncluding anchoring element 540 and valving members 570.No matter through apex of the heart delivering or other modes, a left side is located in delivery apparatus 506After in ventricle 16, the distal end (including first sheath 520) of delivery apparatus 506 can be advanced through lesion bicuspid valve 32 and enter leftAtrium 18 is located on annulus of mitral valve 80 until encapsulating the part of the second sheath 530 of anchoring element 540 as shown in Figure 13Side.It is then possible to along nearside side while keeping the first sheath 520, anchoring element 540 and fixed valving members 570To the second sheath 530 (far from atrium sinistrum 18) is pulled, until anchoring element 540 discharges (as shown in figure 14) from the second sheath 530.Doctor can adjust anchor by using keeping releasedly or being reversibly coupled to the support with bolting device 550 of anchoring element 540Gu the position (for example, as described above, via hook on anchoring element 540) of element 540.
When anchoring element 540 includes upper supporting piece 542 and lower support element 544, as above described in Fig. 5-Fig. 7 BLike that, upper supporting piece 542 and lower support element 544 can be unfolded in atrium sinistrum 18 and/or radial dilatation.Support with bolting part550 can be drawn proximally, and the protrusion of lower support element 544 and hook are pulled through bicuspid valve 32 and enter left ventricle 16In, while upper supporting piece 542 is maintained in atrium sinistrum 18, and the first sheath 520 with valving members 570 is kept fixed notIt is dynamic.Doctor can operate delivering system by rotatably or longitudinally moving upper supporting piece 542 and lower support element 544 as neededSystem 500, to be properly positioned the upper supporting piece 542 and lower support element 544 of anchoring element 540.
After anchoring element 540 is initially allowed to be unfolded in target area or expand, then doctor can deliverAnchoring control is manipulated along proximal direction while the remaining part including valving members 570 of device 506 can remain stationaryProduct 550, until the lower support element 544 of anchoring element 540 is drawn proximally across annulus of mitral valve 80, so that anchoring element540 upper supporting piece 542 and lower support element 544 is located in the opposite sides of annulus of mitral valve 80.In some embodiments, anchoring memberThe upper supporting piece 542 of part 540 can only be located in left ventricle 16 in lower support element 544 and with chordae tendineae and/or adjacent two pointIt is just released after the left ventricular wall contact of annulus 80.
After anchoring element 540 is properly positioned in annulus 80, the first sheath 520 of encapsulating valving members 570 canWith distad (far from left ventricle 16) mobile set distance, the set distance by coupler component 560 (in figures 14 and 15 byShow in approximate tensioned state) length and locator qualification.Then, the first sheath 520 can keep anchoring element 540 solidMobile to nearside while fixed motionless, until operator feels resistance, this shows as shown in Figure 15 and Figure 16 valve portion like thatPart 570 is correctly positioned in self annulus 80 relative to anchoring element 540.In some embodiments, control unit can quiltIt programs or is configured to include driver plate or knob, driver plate or knob can must be relative to anchoring elements 540 according to valving members 570It is mobile to move fixed range to reach the distance of final position.Control unit with driver plate or knob may be configured so thatWhen valve is in correct position relative to anchoring element 540, there are hard stops.
After in the inner cavity that valving members 570 have been located at anchoring element 540, the first sheath 520 then can be toDistal direction is mobile, while the rest part including anchoring element 540 and valving members 570 of delivery system 500 is kept fixedIt is motionless.As a result, as shown in figure 16, valving members 570 expose and it is radially fully expanded in self annulus 80.In some realitiesApply in example, valving members 570 discharge stage by stage, and valving members 570 can be gradually exposed, to allow valving members 570 gradually andStable radial dilatation.This open stage by stage of valving members 570 can prevent valving members 570 relative to anchoring element540 and self annulus 80 undesirable longitudinal movement.In addition, stage by stage using can permit some further lateral nearsidesMovement, to be properly located valving members 570 relative to anchoring element 540.
The valving members 570 of release can be engaged at least self annulus 80, to also lead to joint element or hook and creamThe further engagement of head flesh or left ventricular wall.If there are barbs on the outer surface of valving members 570, they can also be with oneselfIt is engaged in body bicuspid valve 32 with the structure (including native leaflets) of surrounding.
As shown in figure 17, the control unit for being connected to the proximal end of support with bolting part 550 can be used in support with bolting pipeline 550It is separated with anchoring element 540.Then it can distad be pushed while the other elements for keeping delivery apparatus 506 are fixedSecond sheath 530, until support with bolting part 550 as shown in Figure 18 is completely enclosed by the second sheath 530.It is then possible to logicalIt crosses and pulls the first sheath 520 along proximal direction via the first sheath axis 520 and control unit, while keeping delivery apparatus 506Other elements are fixed, move the first sheath 520 along proximal direction, until proximal end and the second shield of the first sheath 520The distal end of set 530 is adjacent.Then delivery apparatus 506 is removed from patient and retracting delivery apparatus 506 along the path,To which valve prosthesis 510 is suitably remained in appropriate location as shown in Figure 19.
In some embodiments, it can control anchoring element relative to the located in series of valving members and be thus implanted intoThe type or feature of mitral.About positioning, valving members can be located at the distal side of anchoring element, so that for example carefulValving members advance into left ventricle subsequently into atrium sinistrum in anchoring element during sharp direct motion process, or are for example moving through stockValving members advance into atrium sinistrum subsequently into left ventricle in anchoring element during the retrograde process of arteries and veins.In an alternative embodiment,Anchoring element can be located at the distal side of valving members, so that for example through anchoring element during apex of the heart direct motion process in valving membersAdvance into left ventricle subsequently into atrium sinistrum, or during process of for example driving in the wrong direction through femoral artery anchoring element in valving membersAdvance into atrium sinistrum subsequently into left ventricle.Regardless of the relative positioning of anchoring element and valving members, during deliveringAnd be implanted into before, the two structures be positioned in series rather than concentrically with respect to one another or partial concentric position, thus be delivered to fromReduce the diameter of valve prosthesis during body annulus.When being delivered by venous system (passing through artery and/or vein), this is specialIt is unimportant and advantageous.In addition, regardless of the relative positioning of anchoring element and valving members, anchoring element and valving members can be withIt is attached to each other by coupler component, coupler component has fixed length and guides valving members along self bicuspid valveThe inflow of ring-placement of the outflow axis relative to anchoring element.
In addition, in some embodiments, as shown in figure 12, the method for delivering mitral may further includeDischarge non-return valve.Non-return valve can reduce or prevent during implantation process blood to pass through the reflux of annulus of mitral valve.Therefore,This method can also include: that non-return valve is released the position into atrium sinistrum from the second sheath after anchoring element deployment,Wherein, the face bigger than the area of annulus of mitral valve is unfolded so as to cause the fabric of non-return valve in the frame radial dilatation of non-return valveProduct.Then the frame of expansion can vertically move, until it flows to left ventricle from atrium sinistrum in permission blood but does not allow bloodLiquid flows to the position of atrium sinistrum from left ventricle.In some embodiments, the proximal end of non-return valve frame is attached to frame control pipeLine, but in some embodiments, the proximal end of non-return valve can be attached to anchoring element control casing and by anchoring element controlCasing control processed.After being implanted into valve prosthesis, non-return valve is removed as a part of delivery apparatus from patient.
Figure 13-Figure 19 illustrates only some embodiments of the method for delivering mitral as described herein, butIt is that delivery apparatus can be configured to the direct motion delivering for valve prosthesis and open and drive in the wrong direction deliver and open in an alternate manner.For example, anchoring element can be closed in the first sheath, the first sheath is located at the second sheath distal side, and valving members are closed inIn second sheath.Therefore, the first sheath can pass through bicuspid valve advance from left ventricle and reach atrium sinistrum, wherein the first sheath existsAbove annulus of mitral valve.Then, as described above, anchoring element can expose and allow that the more supporting elements of upper part are unfolded, thenIt is pulled along proximal direction until being properly positioned in annulus.At this point, having the second sheath of the valving members being closed canTo be moved along distal direction, as described above, moving distance depends on the length of coupler component.After being properly positioned, the first shieldSet is moved along proximal direction, to expose and discharge valving members, and removes delivery apparatus from patient.
Implantation disclosed herein and delivering method and valve prosthesis device can be used for retrograde approach, in side of driving in the wrong directionIn method, the distal end of delivery system initially enters atrium dextrum.In retrograde approach, for example, valving members can be enclosed in distal sideIn first sheath, and anchoring element is enclosed in the second sheath of adjacent nearside.Therefore, the first sheath is advanced through two pointsValve partially or even wholly enters left ventricle, so that the second sheath is located above annulus of mitral valve still in atrium sinistrum.Along nearsideDirection pulls the second sheath to expose anchoring element, to allow anchoring element radial dilatation.Then anchoring element can advanceIt is fitted using imaging device by longitudinal (inflow-outflow axis) movement and rotary motion across annulus of mitral valve, and optionallyLocality positioning.After anchoring element is properly oriented, the first sheath is moved along proximal direction, until its consolidating because of coupler componentMeasured length and meet obstructions.After along longitudinal be properly located, the first sheath can be while keeping valving members to stablizeIt is distally moved, to be gradually exposed and discharge valving members.Then delivery apparatus is removed from patient.
The retrograde delivering of mitral as described herein can also be performed, wherein anchoring element is closed in distal sideThe first sheath in, and valving members are closed in the support sheath of adjacent nearside.Therefore, the first sheath advances through activelyArteries and veins enters in atrium sinistrum the position reached substantially above self annulus of mitral valve, at this time the first sheath be advanced further with expose andDischarge anchoring element.As described above, anchoring element can be partially advanced across annulus of mitral valve, and optionally using imaging dressIt sets through transverse direction and rotary motion and is properly located anchoring element.As described above, after anchoring element is properly positioned, theTwo sheaths are moved along proximal direction, and until its regular length because of coupler component meets obstructions, and valving members are graduallyExpose and discharges in self annulus.Then delivery apparatus is removed from patient.It should be appreciated that the requirement valve of this methodComponent and anchoring element with the orientation positions that for example orientation is opposite described in Figure 11 A- Figure 11 C in each sheath so thatThe upper supporting piece and lower support element of anchoring element and the leaflet of valving members are suitably orientated in an appropriate direction, to plantControl to mitral blood flow is passed through is provided after entering.
Component is assembled by autologous tissue
Some embodiments of apparatus and method as disclosed herein can optionally include native valve sealing device, should be certainlyBody valve sealing device can be incorporated into the structure of device or be realized using individual component.Native valve sealing device can be withIt is closer and No leakage for being generated between other autologous tissues in mitral and native leaflets and/or ventricular sideEngagement.Native valve sealing device can be equipped with during initial mitral implantation process or subsequent makeover process orIt is discharged into target area.Figure 20 A- Figure 27, which is shown, can be implemented to provide some optional implementations of native valve sealing deviceThe various aspects and feature of example.
For example, it may include optional autologous tissue's aggregated structure that Figure 20 A- Figure 21 B, which is shown in accordance with some embodiments,Anchoring element embodiment.Figure 20 A and Figure 20 B show the anchoring similar with above-mentioned anchoring element shown in Fig. 8 A and Fig. 8 BThe embodiment of element 600, anchoring element 600 may include aggregation arm 602.Aggregation arm can be upwardly extended from hook element.Fig. 8 ARadially it can be incorporated into Figure 20 A and Figure 20 B with upward direction hook element outstanding relative to anchoring element with shown in Fig. 8 BShown in design in.However, as shown, aggregation arm 602 can in bending part 604 from the end of anchoring element 600 toLowerly, continuously and upward extend, this can enable aggregation arms 602 radially to deviate in anchoring element 600Mandrel line.Therefore, no matter anchoring hook whether be integrated to shown in design in, bending part can allow anchoring hook 602 canDeviate central axis, to allow the autologous tissues such as leaflet to be placed in the inner ring 610 of anchoring element 600 and by aggregation arm 602Between the outer ring 612 of formation.In this way, native valve tissue can be sealed around anchoring element, to reduce false around valveThe leakage and reflux of body.
Embodiment shown in embodiment shown in Figure 20 A and Figure 20 B and Figure 21 A and Figure 21 B the difference is that: figureThe aggregation arm 602 of embodiment shown in 21A and Figure 21 B can interconnect (therefore, anchoring element 600 shown in Figure 20 A and Figure 20 BFeature element number and Figure 21 A and Figure 21 B shown in anchoring element 620 element number it is shared).For example, in any instituteShow in embodiment, the wire frame of anchoring element may include the knot with continuous, continual route winding to generate anchoring elementThe single wire rod of structure and feature.The end of wire rod can be welded together, to form continuous, continual ring.However,The multiple independent separate parts being bonded together by bonding operation (such as welding, adhesive or mechanical device) can be usedForm anchoring element.
Figure 22 and Figure 23 shows the valve portion in disengaged construction of mitral 700 in accordance with some embodimentsThe embodiment of part and anchoring element.The figures illustrate with above with reference to Fig. 5 and Fig. 6 discuss and shown in the similar knot of structureStructure.However, anchoring element 620 is shown as the central axis towards prosthese 700 in the illustrated embodiment of mitral 700Line assembles the flexible connector of prosthese 700 or the mode of tubular skirt.In addition, as above for described in Figure 20 A- Figure 21 B,The aggregation arm of anchoring element 620 can not only flock together flexible connector, but also can collect and provide self groupKnit the sealing between the anchoring element and valving members of prosthese 700.
Figure 24-Figure 27 shows another optional self valve in accordance with some embodiments that can be implemented with valve prosthesis 720The feature and aspect of film sealing device.In these figures, the various aspects for the system having been discussed above are shown, in order to succinctly riseSee and is not repeated to discuss, it can be after valve prosthesis 720 has been implanted within target position, in the anchor for surrounding valve prosthesis 720Gu introducing aggregation wire rod 722 around the autologous tissue of element.Aggregation wire rod can be stretched in valve prosthesis 720 and be contained inIt is introduced into after its final position appropriate.Aggregation wire rod can be located in prosthese 720 weeks by some embodiments of this methodIt encloses, so that autologous tissue is gathered between prosthese 720, it is tight to be generated between autologous tissue and the outside of valve prosthesis 720Sealing.Figure 24 shows the aggregation wire rod 722 in relaxed state, and Figure 25 shows clamping or is clamped in valve prosthesisAggregation wire rod 722 around 720.In addition, Figure 26 (is similar to Figure 14 discussed above, is not repeated herein for simplicityIts details) show the prosthese 720 being implanted in native valve structure, wherein and 724 clamping of autologous tissue or capture are in aggregation lineBetween material 722 and valve prosthesis 720.
Figure 27 (being similar to Figure 14 discussed above, its details is not repeated herein for simplicity) is shown according to oneA little embodiments when opening non-return valve optionally using assemble wire rod 722 for the use of.In addition to the discussion above for Figure 14Except, when opening non-return valve during operation, aggregation wire rod 722 can be used for capturing and generating autologous tissue and non-return flapSealing between film.As shown, and in any embodiment shown in Figure 24-Figure 27, aggregation wire rod 722 can pass through energyThe independent inner-cavity structure 726 for enough extending through the sheath of delivery system opens.
The slitting item explanation of subject technology
For convenience's sake, the various examples of each aspect of the present invention are described as the item item (1,2,3 etc.) being numbered.ThisA little item items are provided as example, and do not limit this subject technology.The mark of attached drawing and appended drawing reference is only provided belowIt as example and is for the purpose of illustration, and item item is not limited to these marks.
A kind of mitral of item item 1., comprising: upper supporting piece, the self annulus of mitral valve for being configured to neighbouring patient are fixedPosition, and including front and rear；Lower support element is configured to engage self bicuspid valve from ventricular side, and including at least twoA joint element；Flexible connector comprising be connected to the upper end of upper supporting piece and be connected to the lower end of lower support element；WithAnd valving members comprising outer surface and central lobe mouth, valving members can be arranged among upper supporting piece and lower support element, valveMembrane element radial dilatation and can be allowed after valving members expansion along prosthese in lower support element with abutting self bicuspid valveCentral axis passes through self mitral one-way flow；Wherein, lower support element and upper supporting piece are from collapsed configuration energy radial dilatationTo expanded configuration, for being delivered in patient's body.
The valve prosthesis according to item item 1 of item item 2., wherein upper supporting piece includes first annular component.
The valve prosthesis according to item item 2 of item item 3., wherein the top view of first annular component includes generally D-shaped knotStructure.
The valve prosthesis according to any one of aforementioned item item of item item 4., wherein under expansion state, upper supporting pieceRear portion extends in the first plane.
The valve prosthesis according to any one of aforementioned item item of item item 5., wherein the rear portion of upper supporting piece includes semicircleShape shape.
The valve prosthesis according to any one of aforementioned item item of item item 6., wherein the front of upper supporting piece is along oppositeIn the axis bending that central axis extends transversely with.
The valve prosthesis according to item item 6 of item item 7., wherein under expansion state, the front of upper supporting piece is secondExtend in plane.
The valve prosthesis according to item item 6 of item item 8., wherein the front of upper supporting piece includes semicircular in shape.
The valve prosthesis according to any one of aforementioned item item of item item 9., wherein the rear portion of upper supporting piece is flat firstExtend in face, and the front of upper supporting piece extends in the second plane, and the first plane relative to the second plane laterallyExtend.
The valve prosthesis according to item item 9 of item item 10., wherein rear portion includes semicircular in shape, and front includes halfCircular shape.
The valve prosthesis according to any one of aforementioned item item of item item 11., wherein flexible connector includes tubular shapeShape.
The valve prosthesis according to any one of aforementioned item item of item item 12., wherein flexible connector include about 5mm extremelyThe longitudinal length of about 25mm.
The valve prosthesis according to item item 12 of item item 13., wherein upper supporting piece can relative to lower support element it is fixed away fromFrom interior movement, and the fixed range is approximately equal to the longitudinal length of flexible connector.
The valve prosthesis according to any one of aforementioned item item of item item 14., wherein flexible connector includes fabric materialMaterial.
The valve prosthesis according to any one of aforementioned item item of item item 15., wherein under expansion state, flexible connectionDevice includes tapered tubular shape.
The valve prosthesis according to any one of aforementioned item item of item item 16., wherein valving members include valve frame andMultiple artificial leaflets of flexibility, multiple flexible artificial leaflets are connected to valve frame in central lobe mouth.
The valve prosthesis according to item item 16 of item item 17., wherein valve frame includes self-expanding tubular frame.
The valve prosthesis according to item item 16 of item item 18., wherein valve frame includes balloon-expandable tubular frame.
The valve prosthesis according to any one of aforementioned item item of item item 19., wherein valving members include surrounding its appearanceThe coating member that face extends.
The valve prosthesis according to item item 19 of item item 20., wherein coating member includes flexible fabric material.
The valve prosthesis according to any one of aforementioned item item of item item 21., wherein valving members are stitched by least oneIt closes component and is connected to lower support element.
The valve prosthesis according to item item 21 of item item 22., wherein the length of suture part is about 5mm to about 25mm.
The valve prosthesis according to any one of aforementioned item item of item item 23., wherein lower support element includes multiple arch portionsPoint, each arcuate section extends among corresponding joint element, to form lower support element.
The valve prosthesis according to item item 23 of item item 24., wherein each arcuate part is along relative to central axis crossThe axis bending extended to ground.
The valve prosthesis according to any one of aforementioned item item of item item 25., wherein lower support element includes the second ring partPart, at least two joint elements are connected to the second annular element.
The valve prosthesis according to any one of aforementioned item item of item item 26., wherein at least two joint elements includeHook.
The valve prosthesis according to any one of aforementioned item item of item item 27., wherein at least two joint elements include theOne hook and second hook, and the distance between the first hook and second hook are about 30mm to about 90mm.
The valve prosthesis according to any one of aforementioned item item of item item 28., wherein at least two joint elements include threeA hook.
The valve prosthesis according to any one of aforementioned item item of item item 29., wherein at least two joint elements include extremelyThe fabric or suture material partially extended along the surface of joint element.
The valve prosthesis according to any one of aforementioned item item of item item 30., further includes the circumference for being connected to upper supporting pieceFilling component.
The valve prosthesis according to item item 30 of item item 31., wherein filling component includes tubular form and is connected to branchThe upper part of the circumference of support member.
The valve prosthesis according to item item 30 of item item 32., wherein filling component includes textile material.
The valve prosthesis according to item item 1 of item item 33. further includes coupler component, and coupler component, which has, to be connected toThe first end of anchoring element and the second end for being connected to valving members, coupler component limit anchoring element and valving membersBetween length travel.
The valve prosthesis according to item item 33 of item item 34., wherein coupler component includes multiple conductive structures.
The valve prosthesis according to item item 33 of item item 35., wherein coupler component include fabric sheet, suture orTubular cloth.
The valve prosthesis according to any one of item item 33 to 35 of item item 36., wherein the first end of coupler componentIt is connected to the upper supporting piece of anchoring element, and the second end of coupler component is connected to the lower part of valving members, connectorThe longitudinal overlap of component limitation anchoring element and valving members.
A kind of mitral of item item 37., comprising: anchoring element comprising upper supporting piece, lower support element and flexible connectionDevice, the self annulus of mitral valve that upper supporting piece is configured to neighbouring patient position, and lower support element is configured to engage self two from ventricular sideCusp, flexible connector include the upper end for being connected to upper supporting piece and the lower end for being connected to lower support element；And valve portionPart, is connected to lower support element, valving members can in lower support element radial dilatation, to abut self bicuspid valve.
The valve prosthesis according to item item 37 of item item 38. further includes appointing for the valve prosthesis according to item item 1-31What feature.
A kind of valve prosthesis delivery system of item item 39., comprising: mitral comprising upper supporting piece, lower support element,Upper supporting piece is connected to the flexible connector of lower support element, is connected to the valving members of lower support element, upper supporting piece is configured toThe self annulus of mitral valve of neighbouring patient positions, and lower support element is configured to engage self bicuspid valve from ventricular side, and valving members can beRadial dilatation in lower support element, to abut self bicuspid valve；And delivery apparatus comprising core components are connected to core componentsFirst sheath extends on core components and close to the second sheath of the first sheath, wherein delivery apparatus can protect valve prosthesisIt holds in collapsed configuration, wherein the first sheath surrounds at least part of valving members, and the second sheath surrounds upper supporting piece underAt least part of supporting element, and the first sheath and the second sheath can be moved to expose upper supporting piece and lower support element, it willValve prosthesis is anchored at patient's body, and valving members are hereafter discharged in lower support element.
The delivery system according to item item 39 of item item 40., wherein the distal part of valving members is close by the first sheathSide section is surrounded, and the portions of proximal of valving members is surrounded by the distal part of the second sheath.
The delivery system according to item item 39 or 40 of item item 41., wherein lower support element includes multiple joint elements, andAnd delivery apparatus further includes multiple support with bolting components, and when valve prosthesis is in collapsed configuration, multiple support with bolting component energyIt is connected to joint element to release.
The delivery system according to item item 41 of item item 42., wherein multiple support with bolting components are longitudinal in the second sheathGround extends.
The delivery system according to item item 41 of item item 43., wherein multiple support with bolting components can be relative to the second sheathIt is mobile.
The delivery system according to any one of item item 39-43 of item item 44., wherein the lower end of flexible connector is attachedIt is connected to lower support element, and the upper end of flexible connector is attached to upper supporting piece.
The delivery system according to any one of item item 39-44 of item item 45., wherein the lower end of flexible connector is attachedIt is connected to lower support element, and the upper end of flexible connector is attached to upper supporting piece.
The delivery system according to any one of item item 39-45 of item item 46., wherein valve prosthesis includes according to item item 1To valve prosthesis described in any one of 33.
A kind of method for mitral to be implanted into the heart of patient in need of item item 47., comprising: valve is providedFilm prosthesis delivery system and mitral, delivery system include core components, the first sheath for being connected to core components, along coreThe second sheath that part extends, the first sheath are located in the distal side of the second sheath, and mitral includes upper supporting piece, lower supportUpper supporting piece is connected to the flexible connector of lower support element, is connected to the valving members of lower support element by part, and the first sheath surroundsAt least part of valving members, the second sheath surround upper supporting piece and lower support element；Second sheath surrounds upper supporting piece underAt least part of supporting element, the self annulus of mitral valve that upper supporting piece is configured to neighbouring patient position, lower support element be configured to fromVentricular side engages self bicuspid valve, valving members energy radial dilatation in lower support element, to abut self bicuspid valve；It is by deliveringAt least distal portions of system are inserted into the heart of patient；Valve prosthesis is discharged into the self annulus of mitral valve against patient；WithAnd delivery system is removed from patient.
The method according to item item 47 of item item 48., wherein the insertion includes by being formed in the apex of the heart of heartThe distal portions of delivery system are inserted into the left ventricle of heart by opening.
The method according to item item 48 of item item 49. further includes before release promoting the distal portions of delivery systemInto the atrium sinistrum of heart.
The method according to item item 48 or 49 of item item 50. further includes the first sheath before release by delivery systemIt is advanced in the atrium sinistrum of heart.
The method according to any one of item item 47-50 of item item 51., wherein the release includes: to proximal retraction theTwo sheaths, to allow the expansion of upper supporting piece；And upper supporting piece is located near the self annulus of mitral valve of patient.
The method according to item item 51 of item item 52., wherein the release further include: to the second sheath of proximal retraction, withAllow the expansion of lower support element；And lower support element is located against bicuspid valve from ventricular side.
The method according to any one of item item 47-52 of item item 53., wherein the release includes: permission upper supporting pieceWith lower support element heart atrium sinistrum intramedullary expansion；And in the left ventricle for nearside lower support element being pulled in heart.
The method according to item item 52 of item item 54., wherein delivery system includes the re-spective engagement for being connected to lower support elementMultiple support with bolting components of component, and the release further includes being detached from multiple support with bolting components with joint element to connectIt closes, to allow lower support element to expand from ventricular side against bicuspid valve.
The method according to item item 54 of item item 55. further includes mobile multiple support with bolting components, relative to self twoCusp relocates lower support element.
The method according to item item 54 of item item 56., further include allow joint element and self mitral commissura anterior portion,Postcommissure portion and posterior valve leaflet engagement.
The method according to any one of item item 47-56 of item item 57., wherein the release includes by upper supporting pieceEvery alignment under aorta-bicuspid valve of front and self annulus of mitral valve.
The method according to item item 57 of item item 58., wherein the front of upper supporting piece extends in perpendicular, andThe alignment include perpendicular is aligned under the aorta-bicuspid valve for indicating self annulus of mitral valve every 0 degree to 20 of lineIn degree.
The method according to item item 58 of item item 59., wherein the alignment includes that perpendicular is aligned in expression selfUnder aorta-bicuspid valve of annulus of mitral valve every about 10 degree of line in.
The method according to any one of item item 47-59 of item item 60., wherein the release includes by upper supporting pieceLater half circular portion is aligned with the rear annulus of self annulus of mitral valve.
The method according to any one of item item 47-59 of item item 61. further includes that autologous tissue and prosthese are gathered in oneIt rises.
The method according to item item 61 of item item 62., wherein autologous tissue and prosthese flock together including dischargingAggregation wire rod is located in autologous tissue and Periprosthetic after prosthese.
The method according to item item 61 or 62 of item item 63., wherein autologous tissue and prosthese flock together including makingThe aggregation arm of prosthese is engaged with autologous tissue.
Further embodiment
In some embodiments, any item herein may rely on any one of independent strips item or subordinate item itemAny one of.In some embodiments, any item (for example, subordinate item item or independent strips item) can be one with any otherOr multiple item (for example, subordinate item item or independent strips item) combinations.In some embodiments, claim may include in itemSome or all of word described in item, sentence, phrase or paragraph (such as step, operation, device or component).SomeIn embodiment, claim may include some in the word described in one or more item items, sentence, phrase or paragraphOr all.In some embodiments, some words in each item, sentence, phrase or paragraph can be removed.In some implementationsIn example, other words or element can be added to item item, sentence, phrase or paragraph.It in some embodiments, can be unfavorableThis subject technology is realized in the case where some components as described herein, element, functions or operations.In some embodiments, may be usedTo realize this subject technology using other component, element, functions or operations.
Foregoing description is provided so that those skilled in the art can practice various constructions as described herein.Although by reference toThis subject technology has been described in detail in various attached drawings and construction, but it is to be understood that these are solely for the purpose of illustration, without answeringWhen the range for being viewed as a limitation this subject technology.
There may be many other modes to realize this subject technology.Without departing from the scope of the subject technology the case whereUnder, various functionality described herein and element can differently be divided with the function and element shown.To each of these constructionsKind modification will be apparent those skilled in the art, and generic principles defined herein can be applied to other structuresIt makes.Therefore, in the case where without departing from the scope of the subject technology, those skilled in the art can be to this subject technologyCarry out many changes and modifications.
It should be appreciated that the particular order or level of in the disclosed process the step of are the explanations of illustrative methods.It is based onDesign preference, it should be understood that particular order or level the step of during can rearranging.It may be performed simultaneously some stepsSuddenly.The element of various steps is presented in appended claim to a method in sample order, and is not intended to be limited to be presented specificOrder or level.
As it is used herein, term " distal side " can indicate the mesh such as control unit or region far from delivery apparatusThe position or orientation of punctuate, delivery apparatus be used to valve prosthesis being delivered to native valve annulus.In addition, term " nearside " can be withIndicate the position or orientation closer to the target points such as the control unit of delivery apparatus or region, delivery apparatus be used to deliverValve prosthesis.
As it is used herein, phrase "at least one" (wherein, term "and" or "or" quilt before a series of projectsFor separating any project) the entire list of modification, rather than each member of modification list (that is, each project).Phrase is " at leastOne " do not need at least one of each project that selection is listed；On the contrary, the phrase allows to include following meanings: Ren HeyiAt least one of any combination of at least one of a project and/or project and/or at least one of each project.For example, phrase " at least one of A, B and C " or " at least one of A, B or C " refer to only A, only B or only C；A, any combination of B and C；And/or at least one of each A, B and C.
The terms such as " top " that uses in this disclosure, " bottom ", " front ", " rear portion " should be understood asRefer to arbitrary referential, rather than common Gravity Reference System.Therefore, top surface, bottom surface, front surface and rear surface can be withIn Gravity Reference System upwards, downwards, it diagonally or horizontally extends.
In addition, for using term "comprising", " having " etc. in specification or claims, when in claimIt is middle as transitional word when, it is that such term is intended to inclusive and be interpreted " packet in a manner of being similar to term " includes "It includes ".
Word " exemplary " is used herein to mean that " being used as examplea, instances, or illustrations ".Here depicted as " exampleAny embodiment of property " is not necessarily to be construed as more preferred than other embodiments or advantageous.
Unless otherwise stated, the reference of singular elements is not intended to indicate " one and only one ", but " oneOr multiple ".Male's pronoun (for example, he) includes women and neutral (for example, she and it), or vice versa.Term "some"Refer to one or more.For the sake of underscore and/or italic title and subtitle are only for convenience, subject technology is not limited, andAnd without reference to the explanation of the description to subject technology.It well known to those skilled in the art or later will be abilityAll structure and function equivalents of the element of each construction described well known to the those of ordinary skill in domain through the present inventionBy reference be expressly incorporated herein in and it is intended that this subject technology is covered.It is intended to offer as a tribute in addition, not disclosing hereinTo the content of the public, regardless of whether such disclosure clearly describes in the above description.
Although detailed description includes many details, these details are not necessarily to be construed as limiting the model of this subject technologyIt encloses, and should be construed simply as that the different instances and aspect of subject technology are shown.It should be appreciated that the range of this subject technology includes upperThe other embodiments that Wen Wei is discussed in detail.It without departing from the scope of the invention, can be to subject matter disclosed herein skillArrangement, operation and the details of the method and apparatus of art carry out various other modifications, change and change.Unless otherwise stated,Expression " one and only one " is not intended to the reference of the element of singular, and refers to " one or more ".In addition, device orMethod is not necessarily to solve the problems, such as soluble each (or with achievable each excellent by the different embodiments of present disclosurePoint), to be included within the scope of the disclosure.Herein to " can " and its derivative use should be understood as with certainlyIt looks like the meaning of opposite " possibility " or " optionally ".